• PML Overview
  • PML and
    Clinical
    Vigilance
CLINICAL VIGILANCE

PML AND CLINICAL VIGILANCE

PML is difficult to distinguish from MS, especially early in the disease course. There are no definitive signs or symptoms of PML, and demyelination occurs in both MS and PML. Although MRI lacks specificity for PML, clinical and imaging features may help differentiate between the two diseases.1

Clinical vigilance should be practiced when looking for signs and symptoms that may be associated with PML.1

Evaluation of patients prior to treatment

  • Assess patients previously treated with immunosuppressive or antineoplastic drugs for signs or symptoms of ongoing immune compromise1
  • Perform a pretreatment cranial MRI scan within 3 months of initiating therapy1
  • A test that screens for and confirms the presence of anti-JC virus antibodies is recommended for patients receiving or considering TYSABRI. Click here to learn more.

Look for new signs and symptoms that may be suggestive of PML1

Typical symptoms associated with PML are diverse, progress over days to weeks, and include:

  • Progressive weakness on one side of the body or clumsiness of limbs
  • Disturbance of vision
  • Changes in thinking, memory, and orientation leading to confusion and personality changes

Reference

  1. Kappos L, Bates D, Hartung HP, et al. Natalizumab treatment for multiple sclerosis: recommendations for patient selection and monitoring. Lancet Neurol. 2007;6(5):431-441.
Indication
TYSABRI is indicated as monotherapy for the treatment
of patients with relapsing
forms of multiple sclerosis to delay the accumulation of physical disability and reduce
the frequency of clinical exacerbations. The efficacy of TYSABRI beyond 2 years is unknown. Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate multiple sclerosis therapy. Safety and efficacy in patients with chronic progressive multiple sclerosis have not been studied.

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